SHOULDER SUSPENSION TOWER

Description of Event or Problem

BAXTER RECEIVED A REPORT STATING THAT SHOULDER SUSPENSION TOWER FELL TO THE FLOOR AND KNOCKED A PIECE OF AXIS, MAKING IT IMPOSSIBLE TO GLIDE, SUSPEND OR LOCK. THE DEVICE WAS LOCATED AT THE ACCOUNT AND OCCURRED BEFORE USE. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.

Additional Manufacturer Narrative

THE SHOULDER SUSPENSION TOWER IS DESIGNED TO POSITION, SUPPORT AND/OR DISTRACT THE PATIENT¿S SHOULDER IN A VARIETY OF SURGICAL PROCEDURES INCLUDING, BUT NOT LIMITED TO LATERAL ARTHROSCOPIC AND MINI-OPEN SHOULDER SURGERY. THESE DEVICES ARE INTENDED TO BE USED BY HEALTHCARE PROFESSIONALS WITHIN THE OPERATING ROOM SETTING. DURING ON-SITE INSPECTION, BAXTER TECHNICIAN FOUND THE TRIGGER SPRING BROKEN, THE STOP PIN MISSING AND THE PULLEY CLUTCH STUCK. TECHNICIAN REPLACED THE DAMAGED PARTS. BASED ON THIS INFORMATION, NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME. ALTHOUGH THERE WAS NO REPORTED INJURY WITH THIS EVENT, IF THE REPORT OF SHOULDER SUSPENSION TOWER COLLAPSING WERE TO RECUR, IT COULD POTENTIALLY CAUSE SERIOUS INJURY OR DEATH. THEREFORE, BAXTER IS REPORTING THIS EVENT.